WILLOWBROOK, IL, USA I April 27, 2020 I Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced that sovateltide, an endothelin-B receptor agonist, significantly (p=0.0157; two-tailed unpaired t-test; t=2.476; df=70) improved modified Rankin Scale (mRS) of acute cerebral ischemic stroke patients when compared to patients receiving the best standard of care. These results are based on an interim 30-day analysis of multicentric, randomized, blinded, controlled efficacy clinical trials (NCT04046484; NCT04047563) in acute ischemic stroke patients. Modified Rankin Scale in patients receiving sovateltide had a difference of means of 2.40 (95%CI of difference 1.99 to 2.80; N=35) whereas in control patients the difference of means was 1.64 (95%CI of difference 1.22 to 2.07; N=37). Modified Rankin Scale is the recommended and most frequently used primary outcome scale in acute cerebral ischemic stroke clinical trials. National Institutes of Health Stroke Scale (NIHSS) improved with sovateltide (difference of means=7.00) compared to control (difference of means=6.23) and Barthel Index (BI) also improved with sovateltide (difference of means=47.36) compared to control (difference of means=42.30), however, they did not reach the level of statistical significance. The study is continuing to enroll patients and monitor patients till 90 days post randomization. Sovateltide was administered intravenously within 24 hours after the onset of stroke. No incidence of drug related adverse event was reported. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that has the potential to significantly improve neurological outcome in acute cerebral ischemic stroke patients.
Since US FDA recommended, in our pre-IND meeting, to keep mRS as the primary endpoint, we are encouraged by these results and planning to move forward with IND submission to the US FDA. In addition, the Company is continuing multicentric, randomized, double blind, parallel, saline controlled clinical trials using sovateltide in Alzheimer’s disease (NCT04052737) and acute spinal cord injury (NCT04054414). Both studies have crossed 50% of enrollment.
About Pharmazz, Inc.
Pharmazz, Inc. is a privately held company engaged in the development of novel products in the area of critical care medicine. Additional information may be found on the Company’s website, www.pharmazz.com.
SOURCE: Pharmazz
Post Views: 50
WILLOWBROOK, IL, USA I April 27, 2020 I Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced that sovateltide, an endothelin-B receptor agonist, significantly (p=0.0157; two-tailed unpaired t-test; t=2.476; df=70) improved modified Rankin Scale (mRS) of acute cerebral ischemic stroke patients when compared to patients receiving the best standard of care. These results are based on an interim 30-day analysis of multicentric, randomized, blinded, controlled efficacy clinical trials (NCT04046484; NCT04047563) in acute ischemic stroke patients. Modified Rankin Scale in patients receiving sovateltide had a difference of means of 2.40 (95%CI of difference 1.99 to 2.80; N=35) whereas in control patients the difference of means was 1.64 (95%CI of difference 1.22 to 2.07; N=37). Modified Rankin Scale is the recommended and most frequently used primary outcome scale in acute cerebral ischemic stroke clinical trials. National Institutes of Health Stroke Scale (NIHSS) improved with sovateltide (difference of means=7.00) compared to control (difference of means=6.23) and Barthel Index (BI) also improved with sovateltide (difference of means=47.36) compared to control (difference of means=42.30), however, they did not reach the level of statistical significance. The study is continuing to enroll patients and monitor patients till 90 days post randomization. Sovateltide was administered intravenously within 24 hours after the onset of stroke. No incidence of drug related adverse event was reported. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that has the potential to significantly improve neurological outcome in acute cerebral ischemic stroke patients.
Since US FDA recommended, in our pre-IND meeting, to keep mRS as the primary endpoint, we are encouraged by these results and planning to move forward with IND submission to the US FDA. In addition, the Company is continuing multicentric, randomized, double blind, parallel, saline controlled clinical trials using sovateltide in Alzheimer’s disease (NCT04052737) and acute spinal cord injury (NCT04054414). Both studies have crossed 50% of enrollment.
About Pharmazz, Inc.
Pharmazz, Inc. is a privately held company engaged in the development of novel products in the area of critical care medicine. Additional information may be found on the Company’s website, www.pharmazz.com.
SOURCE: Pharmazz
Post Views: 50
